FDA Gives a Thumbs Up to Designer Babies by 23&Me

The Food and Drug Administration (FDA) has finally given 23&Me (23M) their approval to market their designer baby kit to be used to determine genetic markers for Bloom Syndrome (BS), a condition associated with "short stature, sun sensitivity, and increased cancer risk."

23M is a genetics corporation owned by Anne Wojcicki, estranged wife of Google founder Sergey Brin, and funded by Google and Google Ventures with an initial investment of $161 million.

The National Institutes of Health (NIH) describes BS as "an inherited disorder" affecting those born with "low birth weight and length" who "remain much shorter and thinner than others in their family, growing to an adult height of less than 5 feet."

This disorder "is more common in people of Central and Eastern European (Ashkenazi) Jewish background, among whom about 1 in 50,000 are affected. Approximately one-third of people with Bloom syndrome are of Ashkenazi Jewish descent."

Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health (IVDRH) at the FDA Center for Devices and Radiological Health (CDRH) explained: "The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information. [This] authorization and accompanying classification, along with FDA's intent to exempt these devices from FDA premarket review, supports innovation and will ultimately benefit consumers. These tests have the potential to provide people with information about possible mutations in their genes that could be passed on to their children."

Back in June of 2014, 23M was under review by the FDA for their home genetics product that tests and diagnoses for mutations in the genome. In order to determine the genetic traits possible future children will inherit from their parents, clients have their saliva swabbed.

A genetic sample taken from saliva would be run through a gene chip provided by Illumina for deciphering of genetic ancestry and information on genetic risks, propensities and "mutations" that could lead to disease during the individual's lifetime.

The FDA said in November of 2013 the test may "not work as advertised."

In a letter to Wojcicki, the FDA stated: "For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist."

The FDA emphatically said: "[We are] concerned about the public health consequences of inaccurate results from the PGS device. The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work."

Beyond their potential in locating a genetic marker for BS, 23M has the ability to build a custom designed baby through their patented Family Traits Inheritance Calculator (FTIC).

The FTIC will decipher ""what eye colors their child might have or if their child will be able to perceive bitter taste or be lactose intolerant."

Indeed, the clients can peruse a "shopping list" of genetic traits that can be enhanced or suppressed such as:

Wojcicki said: "You could say whether you want a kid with blue eyes or green eyes, a long lifespan, or less risk of colorectal cancer. Or more risk of colorectal cancer, if that's what you're into. The system then runs the database of your genes against others, to recommend a mating match that would be likely to produce a child with said traits."

Essentially, the FTIC assesses if genetic traits can be overcome or avoided.

According to 23M: "The proposed 23andMe calculator is akin to asking someone to be your baby daddy (or mommy) because you think the kids you'd have with them would be cute. That's a stupid reason to raise a child with someone, but it's not morally reprehensible. In the TV show Parks and Recreation, the perpetually single Ann Perkins asks the manic and muscled Chris Traegar to make a baby with her. They're not dating, but she chose him out of other possible baby daddy choices because of his looks (hot), health (A+), and ambition (intense). She wants those traits passed onto her kid."

The patent for the FTIC would have allowed for more "calculated" donors in sperm and egg clinics that will facilitate recipients can evaluate the genetic possibilities when combined with the donor and their own.

Sigrid Sterckx, bioethicst for Ghent University commented : "What 23andMe is claiming is a method by which prospective donors of ova and/or sperm may be selected so as to increase the likelihood of producing a human baby with characteristics desired by the prospective parents, the selection being based on a computerized comparison of the genotypic data of the egg provider with that of the sperm provider."

Sterckx continued: "The use of preimplantation genetic diagnosis to avoid implantation of embryos bearing serious genetic abnormalities is by now becoming commonplace, but a computerized process for selecting gamete donors to achieve a baby with a 'phenotype of interest' that the prospective parent 'desires in his/her hypothetical offspring,' as 23andMe puts it, seems to have much broader implications, for this process also entails the selection of traits that are not disease related."